For in vitro diagnostic use only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.

For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls intended for use in monitoring performance on VITROS Chemistry Systems.

Device Description

The VITROS Chemistry Products dTIBC Reagent is a dual chambered package containing ready-to-use liquid reagents. Reagent 1, an acidic buffer containing ferric ions bound to chromazurol B (iron-binding dye) is added to the sample. The acidic pH releases iron from transferrin and the released iron binds to the excess chromazurol B. Reagent 2, a neutral buffer is added, shifting the pH, which results in increased affinity of transferrin for iron. Serum transferrin rapidly extracts iron from the dye-iron complex. The decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the sample and is measured spectrophotometrically at 660 nm. Once a calibration has been performed, the TIBC concentration in each unknown sample can be determined using the I TDO collection curve and the measured absorbance obtained in the assay of the sample. The VITROS Chemistry Products Calibrator Kit 29 is a two level standard used to calibrate VITRÓS 5,1 FS Chemistry Systems for the quantitative measurement of total iron binding capacity (TIBC). VITROS Calibrator Kit 29 level 1 is an aqueous solution containing processed bovine serum albumin, and preservative. VITROS Calibrator Kit 29 level 2 is a lyophilate containing processed human serum, proteins, enzymes, organic compounds, electrolytes, immunoglobulins, inorganic compounds, hormones, and metals. The VITROS Chemistry Products FS Reconstitution Diluent is processed water used to reconstitute the VITROS Calibrator Kit 29 level 2. The VITROS Chemistry Products Performance Verifiers I and II are lyophilized materials prepared from processed human serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The lypohilate is reconstituted using diluent manufactured from processed water to which inorganic salts have been added. These are assayed quality control materials are used to monitor the performance of the VITROS dTIBC assay on the VITROS 5,1 FS System. The VITROS dTIBC assay utilizes VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline), a common reagent that is used by multiple assays on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 (Saline) is prepared from processed water to which inorganic salt has been added. Diluent 2 (BSA) is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added. The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products.

AI/ML Overview

The provided document, K052867, describes a premarket notification for the VITROS Chemistry Products dTIBC Reagent, Calibrator Kit 29, and Performance Verifiers I & II. This submission focuses on establishing substantial equivalence to previously cleared predicate devices, rather than outlining specific, quantitative acceptance criteria for device performance and detailed study results that would typically be found in a more comprehensive clinical trial report.

Therefore, much of the requested information, such as detailed quantitative acceptance criteria with specific thresholds, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and explicit standalone performance, is not present in this 510(k) summary. The document highlights the comparison to predicate devices to demonstrate equivalence, rather than providing a detailed performance study against pre-defined acceptance criteria.

However, based on the provided text, I can infer and summarize the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a pass/fail format with specific numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" based on correlation studies and bench testing for various assay characteristics.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (VITROS dTIBC vs. Predicate)
Correlation	High correlation coefficient with predicate device.	Correlation coefficient: 0.981
	Linear relationship with predicate device.	Equation: VITROS dTIBC = 0.94X + 12.99 (µg/dL)
Intended Use	Same as predicate device.	Same: Quantitative measurement of TIBC in human samples.
Sample Type	Same/comparable to predicate device.	Difference: Human Serum (VITROS) vs. Human Serum and plasma (Predicate)
Reportable Range	Consistent with clinical utility; comparable to predicate.	Difference: 60 - 650 µg/dL (VITROS) vs. 0 - 1000 µg/dL (Predicate)
Calibrators	Clinically appropriate; comparable to predicate.	Difference: Two levels (VITROS) vs. Three levels (Predicate)
Precision	Expected to be within acceptable analytical limits (not quantified in summary).	Performed (bench testing), but specific results not reported.
Linearity	Expected to be linear across reportable range (not quantified in summary).	Performed (bench testing), but specific results not reported.
Specificity	Expected to be adequate (not quantified in summary).	Performed (bench testing), but specific results not reported.
Limit of Detection	Expected to be clinically relevant (not quantified in summary).	Performed (bench testing), but specific results not reported.
Dilution	Expected to demonstrate appropriate performance (not quantified in summary).	Performed (bench testing), but specific results not reported.
Specimen Matrix	Expected to demonstrate appropriate performance (not quantified in summary).	Performed (bench testing), but specific results not reported.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated. The text mentions "patient samples" were used for equivalence testing.
Data Provenance: Not specified regarding country of origin or whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. For this type of in vitro diagnostic device (quantitative assay), the "ground truth" is typically established by the reference method or the predicate device's established performance, not by expert interpretation of images or other subjective assessments.

4. Adjudication method for the test set

This information is not applicable and not provided for this type of in vitro diagnostic device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic aid for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device is a standalone in vitro diagnostic assay. Its performance is measured directly, not in conjunction with a human operator making interpretive decisions based on the assay's output. The output (a quantitative TIBC value) is directly reported.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence was the performance of the predicate device (Dade Behring Total Iron Binding Capacity (IBCT) Flex® assay on the Dimension® clinical chemistry systems). The new device's measurements were compared against the predicate's measurements on the same samples.

8. The sample size for the training set

This information is not applicable and not provided. This device is a chemical reagent-based assay, not an AI/machine learning algorithm requiring a "training set" in the conventional sense.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no "training set" for this type of device.

Summary

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K052867

inical Diagnostics

DEC 2 3 2005

Columon Johnon company 100 Indigo Creek Drive
Rochester, New York 14626-5101

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:

Submitter name, address, contact	Ortho-Clinical Diagnostics, Inc.100 Indigo Creek DriveRochester, New York 14626-5101(585) 453-4253Contact Person: Darlene Phillips
Preparation Date	October 10, 2005
Device name	Trade or Proprietary Names:VITROS Chemistry Products dTIBC ReagentVITROS Chemistry Products Calibrator Kit 29VITROS Chemistry Products Performance Verifiers I & II
	Common Names:Total iron binding capacity assay
	Classification Names:Iron-binding capacity test system (862.1415): Class: I
	Calibrator (862.1150): Calibrator Kit 29: Class II.
	Quality Control material (assayed and unassayed) (862.1660): Class I (general controls). Since these devices (VITROS Performance Verifiers I & II) are assayed controls, they meet the reserved criteria under Section 510(1) of the Food, Drug, and Cosmetic Act.

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The VITROS Chemistry Products dTIBC assay is substantially equivalent to 4. Predicate the Dade Behring Total Iron Binding Capacity (IBCT) Flex® assay on the Devices Dimension® clinical chemistry systems. The VITROS Chemistry Products Performance Verifiers I and II are substantially equivalent to the VITROS Chemistry Products Performance Verifiers I and II. The VITROS Chemistry Products dTIBC Reagent is used in conjunction with 5. Device the VITROS Chemistry Products Calibrator Kit 29 on the VITROS 5,1 FS description Chemistry Systems for the quantitative measurement of TIBC in human serum. The VITROS Chemistry Products dTIBC Reagent is a dual chambered package containing ready-to-use liquid reagents. Reagent 1, an acidic buffer containing ferric ions bound to chromazurol B (iron-binding dye) is added to the sample. The acidic pH releases iron from transferrin and the released iron binds to the excess chromazurol B. Reagent 2, a neutral buffer is added, shifting the pH, which results in increased affinity of transferrin for iron. Serum transferrin rapidly extracts iron from the dye-iron complex. The decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the sample and is measured spectrophotometrically at 660 nm. Once a calibration has been performed, the TIBC concentration in each unknown sample can be determined using the I TDO collection curve and the measured absorbance obtained in the assay of the sample. The VITROS Chemistry Products Calibrator Kit 29 is a two level standard used to calibrate VITRÓS 5,1 FS Chemistry Systems for the quantitative measurement of total iron binding capacity (TIBC). VITROS Calibrator Kit 29 level 1 is an aqueous solution containing processed bovine serum albumin, and preservative. VITROS Calibrator Kit 29 level 2 is a lyophilate containing processed human serum, proteins, enzymes, organic compounds, electrolytes, immunoglobulins, inorganic compounds, hormones, and metals. The VITROS Chemistry Products FS Reconstitution Diluent is processed water used to reconstitute the VITROS Calibrator Kit 29 level 2. The VITROS Chemistry Products Performance Verifiers I and II are lyophilized materials prepared from processed human serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The lypohilate is reconstituted using diluent manufactured from processed water to which inorganic salts have been added. These are assayed quality control materials are used to monitor the performance of the VITROS dTIBC assay on the VITROS 5,1 FS System.

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The VITROS dTIBC assay utilizes VITROS Chemistry Products FS Diluent 5. Device Pack 2 (BSA/Saline), a common reagent that is used by multiple assays on the description VITROS 5,1 FS System. This is a dual chambered package containing two (continued) ready-to-use liquid diluents. Diluent 1 (Saline) is prepared from processed water to which inorganic salt has been added. Diluent 2 (BSA) is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added. The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products. The VITROS 5, I FS Chemistry System was cleared for market by a separate 510(k) premarket notification (K031924). VITROS Chemistry Products dTIBC Reagent: For in vitro diagnostic use 6. Device only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively intended measure total iron-binding capacity (TIBC) in human serum. uses VITROS Chemistry Products Calibrator Kit 29: For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent. VITROS Chemistry Products Performance Verifiers I & II: For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls used to monitor the performance of VITROS Chemistry Systems. The VITROS Chemistry Products dTIBC Reagent and VITROS Chemistry 7. Comparison Products Calibrator Kit 29 are substantially equivalent to the Dade Behring to predicate Total Iron Binding Capacity (IBCT) Flex® reagent cartridge (K994115) on devices the Dimension® clinical chemistry systems. (K994115) and Dade Behring IBCT Calibrator (K994114) (predicate devices) which were cleared by the FDA for IVD use. The relationship between the VITROS dTIBC assay and the predicate device, determined by least squares linear regression, is: VITROS dTIBC = 0.94 X + 12.99 (μg/dL),
with a correlation coefficient of 0.981, where X is the Dade Behring Total Iron Binding Capacity (IBCT) Flex assay on the Dimension® clinical chemistry system.

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The VITROS Chemistry Products Performance Verifiers I & II are 7. Comparison substantially equivalent to the VITROS Chemistry Products Performance to predicate Verifiers I & II (predicate device) which was cleared by the FDA (K042006) devices for IVD use. (continued)
In addition to correlation studies, bench testing was performed to determine assay precision, linearity, specificity, expected values, limit of detection, dilution and specimen matrix of the VITROS dTIBC assay.

Tables 1 and 2 summarize the similarities and differences between the new devices and the predicates.

Similarities and differences between the VITROS dTIBC assay (new device) Table 1 and the DADE IBCT assay (predicate device).

Similarities
Intended Use	For in vitro diagnostic use only. Used to quantitativelymeasure total iron-binding capacity (TIBC) in humansamples. The iron binding capacity is useful in thedifferential diagnosis of anemia, iron deficiency anemia,thalassemia, sideroblastic anemia, and iron poisoning.
Sample	None required
Pretreatment
Instrumentation	Clinical chemistry analyzer
Calibration	Traceable to NIST SRM 937

Differences
DeviceCharacteristic	VITROS dTIBC assay(New device)	DADE IBCT assay(Predicate device)
Sample Type	Human Serum	Human Serum and plasma
Reportable Range	60 - 650 µg/dL	0 - 1000 µg/dL
Calibrators	Two levels	Three levels

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510(k) Summary (continued)

Similarities and differences between the VITROS Performance Verifiers (new Table 2 device) and the VITROS Performance Verifiers (predicate device).

Similarities
Matrix	The lyophilized performance verifiers are prepared fromprocessed human serum to which enzymes, electrolytes,stabilizers, preservatives, and other organic analytes havebeen added.
Diluent	Manufactured from processed water to which inorganicsalts have been added.
Number of levels	Two

Differences
DeviceCharacteristic	VITROS PerformanceVerifiers(New Device)	VITROS PerformanceVerifiers(Predicate Device)
Indications forUse	For in vitro diagnostic useonly. Assayed controls used tomonitor the performance onVITROS Chemistry Systems.New additional intended use:to monitor performance ofVITROS dTIBC assay onVITROS 5,1 FS ChemistrySystems.	For in vitro diagnosticuse only. Assayedcontrols used to monitorthe performance onVITROS ChemistrySystems.
VITROS assayssupported	VITROS dTIBC MicroTipassay in addition to all of thosesupported by the predicatedevice.	Several assays including.VITROS ALB, TP,TRIG, URIC, LAC, anddHDL, and TIBCMicroSlide® assays andVITROS dHDL anddLDL MicroTip® assays.

The data presented in the premarket notification provide a reasonable assurance Conclusions that the VITROS dTIBC assay and the VITROS Chemistry Products Performance Verifiers are safe and effective for the stated intended uses and are substantially equivalent to the cleared predicate devices.
Equivalence to predicates was demonstrated using commercially available reagents along with patient samples.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

DEC 2 3 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Darlene Phillips Regulatory Associate Ortho-Clinical Diagnostic, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101

Re: K052867

Trade/Device Name: VITROS Chemistry Products dTIBC Regent VITROS Chemistry Products Calibrator Kit 29 VITROS Chemistry Products Chemistry Performance Verifiers I & II Regulation Number: 21 CFR 862.1415 Regulation Name: Iron-binding capacity test system Regulatory Class: Class I Product Code: JMO, JIS, JJY Dated: October 7, 2005 Received: October 11, 2005

Dear Ms. Phillips:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough maing of substantial equivalence of your device to a legally prematics notification: "The results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the I ou may other before, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutz

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):__ K052867

VITROS Chemistry Products dTIBC Reagent Device Name(s): VITROS Chemistry Products Calibrator Kit 29 VITROS Chemistry Products Performance Verifiers I & II For in vitro diagnostic use only. VITROS Chemistry Indications for Use: Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.

For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls intended for use in monitoring performance on VITROS Chemistry Systems.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Ann Chockii
Division Sign-off

Page 1 of __ 1________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K052867

Regulation Number and Section

§ 862.1415 Iron-binding capacity test system.

(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.